NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC)
VETERINARY MEDICINE AND ALLIED PRODUCTS (VMAP) DIRECTORATE
GUIDELINES FOR REGISTRATION OF IMPORTED ANIMAL FEED, PET FOOD AND PREMIX
These guidelines are for the interest of the general public and in particular companies engaged in the importation of Animal feeds, Premixes and Pet food.
No Animal feed, pet food and premix shall be imported, distributed, sold or advertised in Nigeria unless it is regulated in accordance with provisions of NAFDAC ACT CAP N1 LFN 2004.
B. APPLICATION FOR REGISTRATION
An application for registration of an Animal Feed, Pet food and Premixes shall be made by the company’s local representative on company’s letter head and addressed to;
The Director General,
National Agency for Food and Drug Administration and Control (NAFDAC)
ATTN: The Director, Registration & Regulatory Affairs Directorate
No 445, Herbert Macaulay way, Yaba, Lagos.
The applicant shall submit the application with two (2) sets of the following documents to The Liaison Office of the director (LOD), VMAP.
1) Power of Attorney or Contract Manufacturing Agreement
The Power of Attorney shall be:
a) Issued by the manufacturer of the product
b) Signed by the MD, GM, Chairman or President of the Company, stating the names of the products to be registered.
c) Notarized by a Notary public in the country of manufacture.
d) State ownership of brand names (s)/ trademark.
e) Valid for at least five (5) years.
The Contract Manufacturing Agreement shall be:
a) notarized by a notary public in the country of manufacture
b) signed by both parties stating names and designations of the signatories with the names of all products to be registered and other relevant clauses clearly explained in unambiguous language.
2) Manufacturing Licence/ Free Sale Certificate issued:
a) By a relevant Health / Regulatory body.
b) And authenticated by the Nigerian Embassy in that country. In countries where no Nigerian Embassy exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate same.
3) Certificate of registration of brand name/ evidence of trade mark registration from the Federal Ministry of Commerce in Nigeria, done in the name of the owner of the trade mark.
4) Comprehensive Certificate of Analysis of the batch of product registered including radiation free report indicating the name and designation of the analyst.
5) Certificate of business Incorporation of the applicant with Corporate Affairs Commission in Nigeria.
6) A letter of invitation for the inspection of factory abroad from the manufacturer and shall state the name and full location address of factory (not administrative office address); e-mail address, Current phone & Fax No. (office and mobile phones) of contact person overseas; Name of Airport closest to location and guide Map illustrating the shortest land/ Air route to the factory; Name and location address, telephone No., fax No & e-mail address of local agent as well as name(s) of product(s) to be registered.
7) A Notarized declaration in line with the Agency’s format
8) Duly completed Registration form
9) Expired Licence (for product registration renewal)
STEP I: PERMIT TO IMPORT FOR REGISTRATION
Upon satisfactory documentation, import permit (i.e permit to import samples for registration) shall be obtained from the Veterinary Medicines and Allied Products directorate upon the payment of Ten thousand five hundred naira (N10, 500, 5% VAT inclusive) per product.
STEP II: PRODUCT VETTING
Three (3) labeled vetting sample of the products shall be submitted for vetting. Please note that premix pack size shall not exceed 20kg and all medicated premix shall be submitted with dossiers.
STEP III: LABORATORY ANALYSIS
The following are to be submitted for laboratory analysis
a) Copy of payment receipt (Original shall be presented for sighting)
b) Samples of product(s) for laboratory analysis
STEP IV: APPROVAL
Upon receipt of satisfactory laboratory report of samples, products shall be scheduled for approval if the report of the GMP inspection of the facility is also satisfactory.
Upon approval certificate of registration license will be issued, which shall be valid for five (5) years.
It is recommended to commence renewal of registration licence three (3) months before expiration of validity.
D. TARIFFS FOR REGISTRATION
Applicant shall obtain registration form from R&R at the rate of N500 per product.
All payments to the Agency should be in Bank Draft /cash, payable to National Agency for Food and Drug Administration and Control (NAFDAC) account at designated bank.
Registration Fee = ₦150,000 +5% VAT per product
♦Import Permit = ₦10,000 + 5% VAT
♦Laboratory Analysis = ₦20,000 +5% VAT
♦Issuance of Certificate = ₦120,000+5% VAT
a) Cost of registration for products manufactured in ECOWAS countries shall
be 60% of the total cost.
Labeling should be informative and accurate. In addition to the labeling requirements for regulated products, the following information must appear on the label:
a) Name of product-brand must appear in bold
b) The name and the full location address of the manufacturer must be stated on the label in such a manner that is legible.
c) Batch number, Date of manufacture, and Best before/ Expiry date.
d) Net content ( per unit volume or weight).
e) The ingredients must be listed by their common names and quantitatively in order of their predominance by weight.
f) Directions for safe use and appropriate disposal of the packaging material.
g) Where special dietary animal feed/ premix are labeled with claims of disease prevention, treatment, mitigation, cure or diagnosis, it must comply with the guidelines for veterinary medicines and be registered as medicated feed/premix.
h) Provision shall be made for NAFDAC registration number
i) Storage condition shall be indicated
NOTE: Any regulated product which is labeled in a foreign language shall NOT be considered for registration unless an English version is included on the label and package insert (where applicable).
j) The label shall indicate in bold that the product is NOT FOR HUMAN USE
1. AN APPLICATION FOR REGISTRATION DOES NOT CONFER REGISTRATION STATUS ON PRODUCT.
2. FAILURE TO RESPOND PROMPTLY TO CONCERNS RAISED BY NAFDAC ON THE APPLICATION, WILL AUTOMATICALLY LEAD TO DELAY OF FURTHER PROCESSING OF THE APPLICATION.
3. THE LOCAL REPRESENTATIVE IN NIGERIA WITH THE POWER OF ATTORNEY IS RESPONSIBLE FOR ENSURING THAT THE AGENCY IS INFORMED OF ANY SERIOUS HAZARD NEWLY ASSOCIATED WITH A PRODUCT IMPORTED UNDER THE PROVISIONS OF THE ACT OR OF ANY CRIMINAL ABUSE OF QUALITY AND SAFETY.
All correspondence in respect of this application should be addressed to:
The Director (VMAP)
Veterinary Medicines and Allied Products Directorate
No 445 Herbert Macaulay way
E-mail address: email@example.com